K914804

Substantially Equivalent for Some Indications

RADIUS OSTEOTOMY PLATES

Applicant: Link America, Inc.
Product code: HRS
Advisory panel: Orthopedic
Date received: 1991-10-24
Decision date: 1992-04-29
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Hanavor, NJ, US

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.